Medtronic seeks CMS approval for Micra leadless pacemaker
Medtronic plans on seeking coverage from CMS for the company’s Micra Transcatheter Pacing System, the first and only FDA-approved leadless pacemaker.
CMS announced on Jan. 18 that that the agency would cover leadless pacemakers when procedures are performed in FDA-approved studies as well as in prospective longitudinal studies that meet certain criteria.
Medtronic said on Jan. 26 that it would seek coverage of the existing FDA-approved Micra post-approval study and a longitudinal trial that will track data on the use of the Micra system in Medicare patients.
If CMS approves the studies, the Micra will be available to Medicare and Medicaid patients.
The FDA approved the Micra in April 2016 for patients who need a single-chamber pacemaker. The Micra is one-tenth the size of traditional pacemakers and does not require leads or surgical pockets under the skin.
Executive Editor
Tim Casey joined TriMed Media Group in 2015 as Executive Editor. For the previous four years, he worked as an editor and writer for HMP Communications, primarily focused on covering managed care issues and reporting from medical and health care conferences. He was also a staff reporter at the Sacramento Bee for more than four years covering professional, college and high school sports. He earned his undergraduate degree in psychology from the University of Notre Dame and his MBA degree from Georgetown University.